Mechanical friction enhancement for threaded connection incorporating crushable ribs

ABSTRACT

A medical connector includes a body having a distal end, a proximal end, and a sidewall extending between the distal end and the proximal end, a helical thread extending radially outward from a surface of the sidewall and comprising a crest portion, flank portions, and a root portion with the flank portions connecting the crest portion to the root portion, and at least one deformable protrusion extending radially outward from the root portion of the helical thread.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/837,399, filed Dec. 11, 2017, which is a continuation of U.S. patentapplication Ser. No. 14/278,684, filed May 15, 2014 (now U.S. Pat. No.9,968,771), which claims priority to U.S. Provisional Application Ser.No. 61/824,179, filed May 16, 2013, each of which are herebyincorporated by reference in their entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to a connector for enabling fluid transferbetween a first fluid container and a second fluid container. Morespecifically, the invention is directed to a connector having structureto increase friction between threaded connection portions and discourageunintended disconnection.

Description of Related Art

Many medical connectors comprise a first component having a femaleluer-lock element that is arranged to be rigidly joined to acorresponding male luer-lock element of a second connector componentthat is attached to a medical line or other medical connection, forexample. The male-luer lock element can, thus, be freely screwed intoand unscrewed from the female luer-lock element. However, once the maleluer-lock element has been screwed into the female luer-lock element ofthe connector, there is a risk that the connector components may beaccidentally or inadvertently unscrewed, which could lead to thedisconnection of the fluid passage. This may entail a seriouscontamination risk for a patient and/or any other person in the vicinityof the disconnected medical connector. Such a disconnection risk mustespecially be avoided when administering toxic fluid, such as cytostaticagents.

In addition, mechanical perturbations, such as vibrations, rubbing,and/or pulling when the connector is in use may act to loosen theconnection.

It is, therefore, desirable to provide a connection for enabling fluidtransfer between a first fluid container and a second fluid containerthat provides not only some resistance to disconnection but also anindication to the user when the connection has been made and issufficiently tight to proceed with the transfer.

SUMMARY OF THE INVENTION

In one embodiment, a medical connector includes a body having a distalend, a proximal end, and a generally cylindrical sidewall extendingbetween the distal end and the proximal end. The connector furtherincludes a helical thread extending radially outward from a surface ofthe sidewall with the helical thread having a crest portion, flankportions, and a root portion and the flank portions connecting the crestportion to the root portion. At least one deformable protrusion extendsradially outward from the root portion of the helical thread.

A first end and a second end of the at least one deformable protrusionmay be adjacent the flank portions of the helical thread. A radialheight of the at least one deformable protrusion from the surface of thesidewall may be about equal or less than a radial height of the crestportion of the helical thread from the surface of the sidewall. At leastone deformable protrusion may be a rib oriented parallel to a centralaxis of the body of the connector. At least one deformable protrusionmay be a rib oriented perpendicular to a central axis of the body of theconnector. The at least one deformable protrusion may be detachablyconnected to at least one flank portion of the helical thread. The atleast one deformable protrusion may include a score or a notch as aninitiation point for deformation. At least one deformable stop mayextend radially outward from the surface of the sidewall at the proximalend of the connector. The circumferential width of the at least onedeformable stop may decrease as the radial distance of the deformablestop from the surface of the sidewall increases. The circumferentialwidth of the at least one deformable stop may decrease as the axialdistance of the deformable stop from the proximal end of the bodyincreases. The at least one deformable stop may be at a proximal-mostend of the helical thread.

The medical connector may further include a mating connector having abody with a distal end, a proximal end, and a generally cylindricalsidewall extending between the distal end and the proximal end, and ahelical thread extending radially outward from a surface of thesidewall. The helical thread of the mating connector is adapted toengage the helical thread of the connector. The at least one deformableprotrusion may be a triangle-shaped rib. The helical thread may includetwo offset helical threads. The at least one deformable protrusion mayextend between the two helical threads. The medical connector mayfurther include a connector surface positioned adjacent to the proximalend of the body and at least one deformable stop extending from theconnector surface. The at least one deformable stop may be configured toengage a distal end of a mating connector when the medical connector isconnected with the mating connector.

In another embodiment, a method of connecting two fluid containersincludes: providing a connector having a helical thread extendingradially outward from a surface of the connector, and a mating connectorcomprising a helical thread extending radially outward from a surface ofthe mating connector with the connector including at least onedeformable protrusion extending radially outward from a root portion ofthe helical thread; engaging the helical thread of the mating connectorwith the helical thread of the connector; advancing the mating connectoronto the connector by rotating the mating connector; and engaging the atleast one deformable protrusion with the mating connector such that thefriction between the connector and the mating connector is increasedwhen the at least one deformable protrusion of the connector is deformedby the helical thread of the mating connector as the mating connector isadvanced onto the connector.

The deformation of the at least one deformable protrusion may be in thedirection of rotation used to advance the mating connector. The methodmay further include engaging a stop with the mating connector to stopadvancement of the mating connector onto the connector.

In a further embodiment, a medical connector includes a body having adistal end, a proximal end, and a sidewall extending between the distalend and the proximal end, and at least one deformable protrusionextending radially outward from the sidewall of the body with the atleast one deformable protrusion configured to engage a helical thread ofa mating connector such that friction between the connector and themating connector is increased when the at least one deformableprotrusion of the connector is deformed by the helical thread of themating connector. The medical connector may further include at least onedeformable stop extending radially outward from the surface of thesidewall at the proximal end of the connector.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a conventional syringe and syringeadapter.

FIG. 2A is a perspective view of a connector according to one embodimentof the present application.

FIG. 2B is a side view of the connector shown in FIG. 2A according toone embodiment of the present application.

FIG. 2C is a cross-sectional view taken along line 2C-2C shown in FIG.2A according to one embodiment of the present application.

FIG. 3 is a cross-sectional view of a mating connector according to oneembodiment of the present application

FIG. 4A is a perspective view of a connector according to a secondembodiment of the present application.

FIG. 4B is a cross-sectional view taken along line 4B-4B shown in FIG.4A according to one embodiment of the present application.

FIG. 5 is a cross-sectional view of the connector shown in FIG. 2A and amating connector in a connected state according to one embodiment of thepresent application.

FIG. 6 is a perspective view of the connector shown in FIG. 2A afterconnection with the mating connector and deformation of the deformableprotrusions as shown in FIG. 5 .

FIG. 7 is a perspective view of a connector according to a thirdembodiment of the present application.

FIG. 8 is a perspective view of the connector shown in FIG. 7 connectedwith a mating connector according to one embodiment of the presentapplication.

FIG. 9 is a perspective view of a connector according to a fourthembodiment of the present application.

FIG. 10 is a perspective view of connector according to a fifthembodiment of the present application showing the connector connectedwith a mating connector.

DESCRIPTION OF THE INVENTION

For purposes of the description hereinafter, the terms such as “end”,“upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”,“bottom”, “lateral”, “longitudinal”, and derivatives thereof shallrelate to the invention as it is oriented in the drawing figures.However, it is to be understood that the invention may assume variousalternative variations and step sequences, except where expresslyspecified to the contrary. It is also to be understood that the specificdevices and processes illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting. Further, it is to be understood thatthe invention may assume various alternative variations and stepsequences, except where expressly specified to the contrary.

One embodiment of the present invention is directed to a connector 10for fluidly connecting a first fluid container to a second fluidcontainer to allow the fluid in one of the first or second fluidcontainer to pass into the other of the first or second fluid container.For example, the connector 10 may be utilized in connection with thesyringe adapter 24 shown in FIG. 1 . A “fluid container” as used hereinis intended to mean any vessel that can at least temporarily contain afluid, including, but not limited to, a vial, a medical line, a tube, oran infusion fluid container, such as an infusion bottle or an infusionbag, a syringe, or a needle protector device.

Referring to FIG. 1 , a conventional syringe 82 and syringe adapter 24are shown. The syringe 82 includes a male luer-lock connector that isconfigured to be secured to a corresponding female luer-lock connectorof the syringe adapter 24. The syringe adapter 24 may be a BD PhaSeal™Injector commercially available from Becton, Dickinson and Company. Thesyringe adapter 24 forms part of a closed system transfer device thatenables a closed transfer of drugs between containers.

As shown in FIGS. 2A-2C, 4A-7, and 9 , the connector 10 includes a body12 having a distal end 16, a proximal end 18, and a sidewall 20extending between the distal end 16 and the proximal end 18 and defininga central lumen 22. The sidewall 20 may be generally cylindrical. Theconnector 10 may be a female luer-lock connector, although othersuitable connector arrangements may be utilized. The proximal end 18 ofthe body 12 of the connector 10 may be attached directly to a firstfluid container or may extend from an additional connection portion thatconnects directly to the fluid container to provide a fluid connectionbetween the first fluid container and the central lumen 22 of theconnector 10. The body 12 of the connector 10 may extend from a needleholder of a syringe adapter, such as the syringe adapter 24 shown inFIG. 1 . An inner surface of the needle holder may include a projectionthat cooperates with a body of the syringe adapter 24 to form aratchet-type connection such that the needle holder is generally free torotate relative to the body of the syringe adapter 24 in a firstdirection, but is generally restricted from such relative rotation whenrotated in a second, opposite direction.

The body 12 of the connector 10 includes external threads 26 extendingradially outward from the external surface 28 of the sidewall 20 andproceeding in a helical fashion from the distal end 16 to the proximalend 18 of the body 12. In the embodiment shown, the body 12 includes twoexternal threads 26, although one or more threads may be provided. Theexternal threads 26 each comprise flank portions 34, 36, a crest portion38, and a root portion 39. The crest portion 38 and the flank portions34, 36 together define a helical rib 30 and the root portion 39 and theflank portions 34, 36 together define a helical groove 32. The crestportion 38 of the external threads 26 extends radially a distance fromthe external surface 28 of the sidewall 20. The helical ribs 30 may haveany suitable cross-sectional shape, including but not limited to,square, rounded, and trapezoidal. In the embodiment shown in FIGS.2A-2C, 4A-7, and 9 , the helical rib 30 has a generally trapezoidalcross-section with the crest portion 38 positioned a distance from theexternal surface 28 of the sidewall 20 and substantially parallel to theexternal surface 28 of the sidewall 20. The two flank portions 34, 36extend from the crest portion 38 inward toward the external surface 28of the sidewall 20. The angle between the flank portions 34, 36 and theroot portion 39 is greater than 90° as is the angle between the flankportions 34, 36 and the crest portion 38. The shape of the helicalgroove 32 is defined by the flank portions 34, 36 and the root portion39. In the embodiment shown in FIGS. 2A-2C, 4A-7, and 9 , the helicalgroove 32 has a trapezoidal shape. The external threads 26 may extendone or more revolutions around the body 12 of the connector 10 or may bea partial thread that extends less than one revolution around the body12 of the connector 10.

The connector 10 is configured to be secured to and mate with a matingconnector 14, shown in FIGS. 3, 5, 8, and 10 that includes a body 72having a distal end 74, a proximal end, and a generally cylindricalsidewall 78 extending between the distal end 74 and the proximal end anddefining a central lumen 80. The mating connector 14 may be a maleluer-lock connector, although other suitable mating connectors may beutilized. The proximal end of the body 72 of the mating connector 14 maybe attached directly to a first fluid container, for example, thesyringe 82 shown in FIG. 1 , or may extend from an additional connectionportion that connects directly to the fluid container to provide a fluidconnection between the first fluid container and the central lumen 80 ofthe body 72 of the mating connector 14. In the embodiment shown in FIGS.3, 5, 8, and 10 , the mating connector 14 is a male luer-lock.

As shown in FIGS. 3 and 5 , the body 72 of the mating connector 14includes internal helical threads 84 extending radially outward from theinternal surface 86 of the sidewall 78 and proceeding in a spiralfashion from the distal end 74 to the proximal end of the body 72. Inthe embodiment shown, the body 72 includes two internal threads 84,although one or more threads may be provided. The internal threads 84each comprise flank portions 92, 94, a crest portion 96, and a rootportion 97. The crest portion 96 and the flank portions 92, 94 togetherdefine a helical rib 88 and the root portion 97 and the flank portions92, 94 together define a helical groove 90. The crest portion 96 of theinternal threads 84 extends radially a distance from the internalsurface 86 of the sidewall 78. The helical rib 88 may have any suitablecross-sectional shape, including but not limited to, square, rounded,and trapezoidal. The internal threads 84 are shaped and sized to engagethe external threads 26 of the connector 10 so that the body 72 of themating connector 14 can be threaded onto the body 12 of the connector 10and tightened to form the connection.

In the embodiment shown in FIGS. 3 and 5 , the helical ribs 88 have agenerally trapezoidal cross-section with the crest portion 96, adistance from the internal surface 86 of the sidewall 78 andsubstantially parallel to the internal surface 86 of the sidewall 78.The two flank portions 92, 94 extend from the crest portion 96 inwardtoward the internal surface 86 of the sidewall 78. The angle between theflank portions 92, 94 and the root portion 97 is greater than 90° as isthe angle between the flank portions 92, 94 and the crest portion 96.The shape of the helical groove 90 is defined by the flank portions 92,94 and the root portion 97 of the internal threads 84. In the embodimentshown in FIGS. 3 and 5 , the helical groove 90 has a trapezoidal shape.

When a user of the connector 10 desires to make the connection, themating connector 14 is threaded onto the connector 10, such that theinternal threads 84 of the mating connector 14 engage the externalthreads 26 of the connector 10.

The connector 10 has at least one deformable protrusion 40 a, 40 bextending radially outward from the root portion 39 of the externalthread 26 such that it is generally disposed within the helical groove32. The deformable protrusion 40 a, 40 b has a radial height from theexternal surface 28 of the sidewall 20 that is about equal to or lessthan the radial height of the crest portion 38 of the external thread 26from the external surface 28 of the sidewall 20 and a width that may beless than the width of the root portion 39 in the axial direction. Thedeformable protrusion 40 a, 40 b may also have a radial height from theexternal surface 28 of the sidewall 20 that is greater than the radialheight of the crest portion 38 of the external thread 26 from theexternal surface 28 of the sidewall 20. As discussed in more detailbelow, the deformable protrusions 40 a, 40 b are configured to deformupon engagement with a helical thread or threads of a mating connector.

In the embodiment shown in FIGS. 2A-2C, two deformable protrusions 40 a,40 b are disposed in the helical groove 32 such that they form avertical rib that extends axially along the external surface 28 of thesidewall 20 and is substantially parallel to the central axis 46 thebody 12. Each deformable protrusion 40 a, 40 b extends from a first end42 adjacent one flank portion 34 of the external thread 26 to a secondend 44 adjacent to the other flank portion 36. Further, two sets ofdeformable protrusions 40 a, 40 b may be provided to form two verticalribs, although any other suitable number deformable protrusions may beprovided.

In the embodiment shown in FIGS. 4A and 4B, a horizontal deformableprotrusion 140 is disposed in the helical groove 32 extendingcircumferentially along the external surface 28 of the sidewall 20 in adirection that is substantially perpendicular to the central axis 46 ofthe body 12. The deformable protrusion 140 extends from a first end 142adjacent one flank portion 34 of the external thread 26 to a second end144 adjacent to the other flank portion 36.

The deformable protrusions 40 a, 40 b, 140 may or may not be detachablyconnected to the flank portions 34, 36. The deformable protrusions 40 a,40 b, 140 are generally thin, fin-shaped ribs to allow them to deform orbend when a mating connector 14 is threaded onto the connector 10. Anysuitable means allowing for deformation of the deformable protrusions 40a, 40 b, 140 may be used, including but not limited to, the followingarrangements.

The deformable protrusions 40 a, 40 b, 140 may be constructed to have ageometry such that the geometry combined with the strength of thematerial used to make the deformable protrusion 40 a, 40 b, 140 resultsin the deformable protrusion 40 a, 40 b, 140 having insufficientstrength to withstand the force provided when the deformable protrusion40, 140 is contacted by the internal threads 84 of a mating connector 14as the mating connector 14 is threaded onto and advanced onto theconnector 10. For example, as shown in FIGS. 2A-2C, 4A, and 4B, thedeformable protrusions 40 a, 40 b, 140 may have the geometry of a verythin, triangular fin-shaped rib, although other suitable shapes for theprotrusions may be utilized, such as very thin, rectangular fin-shapedribs. The resistance to deformation of the deformable protrusions 40 a,40 b, 140 is related to its width/thickness in the direction in whichforce is applied. In the embodiment shown in FIGS. 2A-2C, 4A, and 4B,force will be applied perpendicular to the vertical deformableprotrusion 40 and tangential to the horizontal deformable protrusion 140when the internal thread 84 of the mating connector 14 contacts thedeformable protrusion 40 a, 40 b, 140 during connection of the matingconnector 14 and the connector 10. Thus, because, in this direction, thecircumferential width of the deformable protrusion 40 a, 40 b is small,the resistance to deformation will be small allowing the deformableprotrusion 40 a, 40 b to bend in the direction in which the force isapplied.

The direction of the vertical deformable protrusions 40 a, 40 b shown inFIG. 2A and the horizontal deformable protrusion 140 shown in FIG. 4Aand their placement extending within the root portion 39 of the externalthread 26 from the first flank portion 34 to the second flank portion 36ensures that the internal thread 84 of the mating connector 14 willalways engage the deformable protrusions 40 a, 40 b, 140 regardless ofthe dimension of the internal thread 84 or the dimensional tolerancebetween the connector 10 and the mating connector 14. Therefore, whilethese deformable protrusions 40 a, 40 b, 140 are shown as substantiallyparallel and perpendicular to the central axis 46 of the body 12,respectively, a person skilled in the art will recognize that they maybe placed at any angle with respect to the central axis 46 between thesetwo positions as long as they are located such that their direction, andplacement in the root portion 39 of the thread 26 and between the flankportions 34, 36 of the thread 26 ensures that the internal thread 84 ofthe mating connector 14 will always engage the deformable protrusion 40a, 40 b, 140 regardless of the dimension of the internal thread 84 orthe dimensional tolerance between the connector 10 and the matingconnector 14.

This can be seen in FIGS. 5 and 6 where a portion, approximately half,of the deformable protrusion 40 a, 40 b has been bent in the directionof rotation. Since, in this case, the internal thread 84 of the matingconnector 14 has an axial width that is less than the axial width of thedeformable protrusion 40 a, 40 b, only a portion of the deformableprotrusion 40 a, 40 b is contacted and deformed by the internal thread84. The horizontal deformable protrusion 140 shown in FIG. 4A would besimilarly deformed.

Although the deformable protrusions 40 a, 40 b, 140 have highinterference with the mating connector 14, the deformable protrusions 40a, 40 b, 140 are thin and deformable and, therefore, some of thedeformable protrusions 40 a, 40 b, 140 will be displaced in order toallow the deformable protrusion 40 a, 40 b, 140 to conform with theinternal threads 84 of the mating connector 14. This results in aconsistent final contact pressure and, therefore, resistive torquewithin a relatively large range of connector 10 and mating connector 14dimensions.

Conventional interference ribs require tight tolerances, as even smallinterferences create large contact stresses, therefore, the dimensionsmust be closely controlled if reasonable control of retention forces isto be attained. This can be especially challenging because althoughconnector designs are often specified by regulating bodies, such as ISO,mating connectors made by other manufacturers can vary significantly indimension even within the standards and may vary from the standards. Thedeformable protrusions 40 a, 40 b, 140 of the present invention are lessdependent on tight tolerances, as they have high interference anddeformation as described above and, because the deformable protrusions40 a, 40 b, 140 are being deformed and displaced, the final contactforce is far less sensitive to the initial interference.

The deformable protrusions 40 a, 40 b, 140 according to embodiments ofthe present invention are also less sensitive to placement and activatemore reliably with a wider range of mating connectors 14 thanconventional arrangements. Because the internal thread 84 of theconnector 10 and the mating connector 14 are both helical, placing ahelical crush rib between the primary threads is challenging. There canbe a wide range in the permissible width and spacing of the threads 26,84 of the connector 10 and the mating connector 14, therefore, ensuringthe helical crush rib is in the right place for engagement for allpossible configurations is difficult. In the present invention, thedeformable protrusions 40 a, 40 b, 140 are not aligned with the externalthreads 26, and, as described above, engagement is ensured.Alternatively, the deformable protrusion 40 a, 40 b, 140 could be scoredor contain a notch that provides a weak point to act as an initiationpoint for deformation of the deformable protrusion 40, 140.

The two mechanisms for deformation may also be used in combination. Forexample, the deformable protrusions 40 a, 40 b, 140 in the form of athin, fin-shaped rib may be detachably connected at its first end 42,142 and second end 44, 144 to the flank portions 34, 36 of the externalthread 26 using a scored, thinner, or notched engagement point havingless strength than the engagement point between the deformableprotrusions 40 a, 40 b, 140 and the root portion 39 of the externalthread 26. In this case, the force provided by the internal threads 84of a mating connector 14 as the mating connector 14 is threaded onto andadvanced onto the connector 10 is sufficient to detach the ends 42, 44,142, 144 of the deformable protrusions 40 a, 40 b, 140 from the flankportions 34, 36 of the external thread 26 and further deform thedeformable protrusions 40 a, 40 b, 140 due to its geometry.Alternatively, the deformable protrusions 40 a, 40 b, 140 may be scoredor contain a notch at a point along its radial height to facilitatebending.

The deformable protrusions 40 a, 40 b may be present in any number, takeany shape, size, and cross-section, and be oriented in any directionwithin the helical groove 32 such that they extend from the root portion39 into the helical groove 32, act to increase friction when theconnector 10 is threaded into a mating connector 14, at least partiallycontact the internal threads 84 of the mating connector 14, and deformwhen the connector 10 is threaded into a mating connector 14.

The maximum radial height of any portion of the deformable protrusions40 a, 40 b, 140 from the external surface 28 of the sidewall 20 is lessthan or equal to the maximum height of any portion of the helical rib 30from the external surface 28 of the sidewall 20.

Any number of deformable protrusions 40 a, 40 b, 140 may be used andvertical deformable protrusions 40 a, 40 b may be used in combinationwith horizontal deformable protrusions 140.

As shown in FIG. 7 , at least one deformable stop 48 may be superimposedover a portion of the proximal-most end 50 of at least one of thehelical ribs 30. The deformable stop 48 extends from both the rootportion 39 of the external thread 26 and the crest portion 38 of theexternal thread 26. The deformable stop 48 comprises a first side 56, asecond side 58, and a bottom 59. The bottom 59 of the deformable stop 48is connected to the distal surface 61 of a fluid container or aconnection portion that will be connected to a fluid container, in thiscase a syringe adaptor 24. The first side 56 and second side 58 of thedeformable stop 48 have a generally triangular surface. As a result, theradial height of the deformable stop 48 from the external surface 28 ofthe sidewall 20 tapers from the bottom 59 of the deformable stop 48towards the distal end 16 of the body 12. This results in the radialheight of the deformable stop 48 from the external surface 28 of thesidewall 20 being at a maximum at its proximal end 18 adjacent theproximal end 18 of the body 12 and at a minimum at its distal end 16.

The connection of the sides 56, 58 of the deformable stop 48 are at anangle to one another such that, for any plane cutting through thedeformable stop 48 perpendicular to the central axis 46 of the body, thedeformable stop 48 has a triangular cross-section. More specifically,for any such plane, the radial height of the deformable stop 48 from theexternal surface 28 of the sidewall 20 is at a maximum at the centerlineof the deformable stop 48 and tapers in both directionscircumferentially such that the radial height of the deformable stop 48from the external surface 28 of the sidewall 20 is at a minimum at thecircumferentially outermost edges of the sides 56, 58 of the deformablestop 48 which are substantially flush with the external surface 28 ofthe sidewall 20.

Because the deformable stop 48 has a triangular cross-sectionperpendicular to the central axis 46 of the body 12, the circumferentialwidth of the deformable stop 48 increases as the distance from theexternal surface 28 of the sidewall 20 decreases. The resistance todeformation of the deformable stop 48 is directly related to itswidth/thickness in the direction in which force is applied. In the caseof the connector 10, force will be applied perpendicular to the secondside 58 of the deformable stop 48 when the internal thread 84 and/or thedistal end 74 of the mating connector 14 contacts the deformable stop 48during connection of the mating connector 14 and the connector 10. Thus,since, in this direction, the circumferential width of the deformablestop 48 increases as the radial distance from the external surface 28 ofthe sidewall 20 decreases, the resistance to deformation will alsoincreases as the radial distance of the deformable stop 48 from theexternal surface 28 of the sidewall 20 decreases resulting in theresistive force provided by the deformable stop 48 increasing as themating connector 14 is advanced onto the connector 10.

Therefore, dependent on the amount of force provided by the internalthread 84 and/or the distal end 74 of the mating connector 14 when theinternal thread 84 and/or the distal end 74 contacts the deformable stop48, a radially outer portion of the deformable stop 48 will deformincreasing the friction between the mating connector 14 and theconnector 10 while a radially inner portion of the deformable stop 48will not deform and will act to stop advancement of the mating connector14. This feature can be seen in FIG. 7 where a radially outer portion ofthe distal end 74 of the deformable stop 48 has been deformed by theinternal threads 84 and/or the distal end 74 of the mating connector 14.

A person skilled in the art can appreciate that the deformable stop 48can, therefore, be adjusted to provide more friction and less stoppingor vice versa by adjusting the geometry of the deformable stop 48 tochange the amount by which the circumferential width of the deformablestop 48 increases as the radial distance of the deformable stop 48 fromthe external surface 28 of the sidewall 20 decreases.

In another embodiment, shown in FIG. 9 , a deformable stop 148 mayinstead comprise a number of portions separated by gaps extending fromthe proximal-most end 50 of at least one of the helical ribs 30. Eachportion of the deformable stop 148 extends radially outward from theexternal surface 28 of the sidewall 20. Each portion comprises a firstside 156, a second side 158, and a bottom 159. The first end 160 of thedeformable stop 148 is adjacent the proximal-most end 50 of one of thehelical ribs 30 and the deformable stop 148 is generally disposed withinthe proximal-most end 68 of the helical groove 32.

The connection of the sides 156, 158 of the deformable stop 148 is at anangle to one another such that, the deformable stop 148 has a triangularcross-section in the axial direction. Because the deformable stop 148has a triangular cross-section in the axial direction, thecircumferential width of the deformable stop 148 increases as the axialdistance from the proximal end 18 of the body 12 decreases. Theresistance to deformation of the deformable stop 148 is related to itswidth/thickness in the direction in which force is applied. In the caseof the connector 10, force will be applied perpendicular to the secondside 158 of the deformable stop 148 when the internal thread 84 and/orthe distal end 74 of the mating connector 14 contacts the deformablestop 148 during connection of the mating connector 14 and the connector10. Thus, since, in this direction, the circumferential width of thedeformable stop 148 increases as the axial distance from the proximalend 18 of the body 12 decreases, the resistance to deformation will alsoincrease as the axial distance of the deformable stop 148 from theproximal end 18 of the body 12 decreases resulting in the resistiveforce provided by the deformable stop 148 increasing as the matingconnector 14 is advanced onto the connector 10.

Therefore, dependent on the amount of force provided by the internalthread 84 and/or the distal end 74 of the mating connector 14 when theinternal thread 84 and/or the distal end 74 contacts the deformable stop148, an axially distal portion of the deformable stop 148 will deformincreasing the friction between the mating connector 14 and theconnector 10 while an axially proximal portion of the deformable stop148 will not deform and will act to stop advancement of the matingconnector 14.

Referring to FIG. 10 , a further embodiment of a deformable stop 248 isshown. The deformable stop 248 is similar as the deformable stop 148shown in FIG. 9 , except for the dimensions of the deformable stop 248.In particular, the deformable stop 248 shown in FIG. 10 is taller andthinner than the deformable stop 148 shown in FIG. 9 . As shown in FIG.10 , the axially proximal portion of the deformable stop 248 has beendeformed by the internal threads 84 and/or the distal end 74 of themating connector 14.

A person skilled in the art can appreciate that the deformable stops148, 248 can, therefore, be adjusted to provide more friction and lessstopping or vice versa by adjusting the geometry of the stop to changethe amount by which the circumferential width of the deformable stops148, 248 decreases as the axial distance of the deformable stops 148,248 from the proximal end 18 of the body 12 increases.

When a user of the connector 10 desires to make the connection, themating connector 14 is threaded onto the connector 10, such that theinternal threads 84 of the mating connector 14 engage the externalthreads 26 of the connector 10. As the user continues to advance themating connector 14 onto the connector 10, the deformable protrusion 40a, 40 b, 140 of the connector 10 is engaged by the internal threads 84of the mating connector 14 and is at least partially deformed as theinternal threads 84 of the mating connector 14 pass over the deformableprotrusion 40 a, 40 b, 140. This results in increased friction and,thus, retention torque between the connector 10 and the mating connector14. The user must then apply increased torque to continue to advance themating connector 14 onto the connector 10. This provides an indicationto the user that the connection is being made and that the connection isbeing tightened. The friction may continue to increase as the matingconnector 14 is advanced onto the connector 10 when the internal thread84 of the mating connector 14 engages additional deformable protrusions40 a, 40 b, 140 until the distal-most end of the internal thread 84and/or the distal end 74 of the mating connector 14 contacts thedeformable stops 48, 148, 248 at the proximal end 18 of the body 12 ofthe connector 10. As the user continues to apply torque to the matingconnector 14, the distal-most end of the internal thread 84 and/or thedistal end 74 of the mating connector 14 of the mating connector 14deforms at least a radially outer portion of the deformable stop 48 oran axially distal portion of deformable stops 148, 248 such that theinternal thread 84 and/or the distal end 74 of the mating connector 14are engaged in a wedging manner by the deformable stops 48, 148, 248.

As will be appreciated by a person skilled in the art, the number, size,shape, and orientation of the deformable protrusions 40 a, 40 b, 140 ischosen to provide the desired amount of friction during connection andretention torque after connection and, if desired, may be chosen toincrease or decrease any additional friction that is provided as themating connector 14 is advanced onto the connector 10. The frictionprovided will increase as the size of the contact area between thedeformable protrusion 40 a, 40 b, 140 and the internal thread 84 of themating connector 14 increases. This can be accomplished either byincreasing the size of the deformable protrusion 40 a, 40 b, 140 or byincreasing the size of the helical rib 88 of the internal thread 84 ofthe mating connector 14. The friction and retention torque will alsoincrease as the quantity of the deformable protrusions 40 a, 40 b, 140is increased. This gives the user a feeling that the connection isconstantly getting tighter and helps to avoid over-tightening of theconnection.

Deformation of the deformable protrusion 40 a, 40 b, 140 and deformablestop 48, 148 will be directional. As the mating connector 14 is advancedonto the connector 10, the force that the internal threads 84 and/or thedistal end 74 of the mating connector 14 exerts on the deformableprotrusions 40 a, 40 b, 140 and deformable stops 48, 148, 248 will be inthe direction of rotation. This will cause the deformable protrusions 40a, 40 b, 140 and deformable stops 48, 148, 248 to deform in thatdirection. If the user tries to disconnect the connectors 10, 14 byreversing the rotation of the mating connector 14, not only will theretention torque provided by the deformed portions of the deformableprotrusions 40 a, 40 b, 140 and the deformable stops 48, 148, 248 act toresist disconnection, but the deformable protrusions 40 a, 40 b, 140 anddeformable stops 48, 148, 248 which are deformed in the direction of theoriginal rotation will act as barbs or stops that will tend to dig intothe internal threads 84 and/or the distal end 74 of the mating connector14 when the direction of rotation is reversed. In addition, if only aportion of the deformable protrusions 40 a, 40 b, 140 is deformed in thedirection of rotation as shown in FIGS. 5 and 6 , the remainingun-deformed portion will also act as a barb or stop that will tend todig into the internal threads 84 of the mating connector 14 when thedirection of rotation is reversed. This will increase the torque neededfor disconnection resulting in more resistance of the connectors 10, 14to accidental disconnection.

Thus, the engagement of both the deformable protrusions 40 a, 40 b, 140and the deformable stop 48, 148, 248 of the connector 10 with theinternal threads 84 and/or the distal end 74 of the mating connector 14results in increased friction and retention torque as the matingconnector 14 is advanced onto the connector 10. This increased frictionand corresponding increase in torque to make the connection provide anindication to the user that the connection between the connector 10 andthe mating connector 14 is being secured. The increased feeling oftightness that is transferred to the user encourages the user to stopapplying torque when the connection is tight and discouragesover-tightening of the connection which can result in breakage of themating connector 14 or the connector 10. In addition, the deformation ofthe deformable protrusions 40 a, 40 b, 140 and deformable stops 48, 148,248 during the connection of the mating connector 14 to the connector 10provides retention torque which makes the connection more resistant todisconnection than a connection that merely utilizes correspondinginternal and external threads and the inherent frictional properties ofthe material.

While the discussion and figures have described the deformableprotrusions 40 a, 40 b, 140 and the deformable stops 48, 148, 248 inconjunction with the body 12 of the connector 10, it can be appreciatedby a person skilled in the art, that the same result may be achieved inthe same manner by incorporating the deformable protrusions 40 a, 40 b,140 and the deformable stops 48, 148, 248 into the mating connector 14.Further, although the deformable protrusions 40 a, 40 b, 140 and thedeformable stops 48, 148, 248 are shown in conjunction with theconnector 10 having external threads 26, such as female luer-lockconnector, the deformable protrusions 40 a, 40 b, 140 and the deformablestops 48, 148, 248 may also be utilized with a connector that does nothave the external threads 26. In particular, the deformable protrusions40 a, 40 b, 140 and the deformable stops 48, 148, 248 may be provided ona thread-less female luer connector with the threads 84 of the matingconnector 14 engaging the deformable protrusions 40 a, 40 b, 140 and thedeformable stops 48, 148, 248 to increase the feeling of tightness andproviding retention torque in generally the same manner as describedabove.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

The invention claimed is:
 1. A medical connector comprising: a bodyhaving a distal end, a proximal end, and a sidewall extending betweenthe distal end and the proximal end; a helical thread extending radiallyoutward from a surface of the sidewall and comprising a crest portion,flank portions, and a root portion, the flank portions connecting thecrest portion to the root portion; at least one deformable stopextending radially outward from the surface of the sidewall at theproximal end of the body; and a connector surface extending from theproximal end of the body, wherein the at least one deformable stopextends from the connector surface in a distal direction.
 2. The medicalconnector according to claim 1, wherein the at least one deformable stopis disposed at a proximal-most end of the helical thread.
 3. The medicalconnector according to claim 1, wherein the at least one deformable stopis configured to engage a distal end of a mating connector when themedical connector is connected with the mating connector.
 4. The medicalconnector of claim 1, comprising a plurality of the at least onedeformable stops extending from the connector surface in the distaldirection and also extending radially outwardly from the surface of thesidewall of the body of the medical connector.
 5. The medical connectorof claim 4, wherein the plurality of the at least one deformable stopsare arranged parallel to one another on the connector surface, andwherein each of the at least one deformable stops is separated fromadjacent deformable stops by a gap.
 6. The medical connector of claim 1,further comprising at least one deformable protrusion separate from theat least one deformable stop, wherein the deformable protrusion extendsradially outward from the root portion of the helical thread, andwherein a first end and a second end of the at least one deformableprotrusion are adjacent the flank portions of the helical thread.
 7. Themedical connector according to claim 6, wherein a radial height of theat least one deformable protrusion from the surface of the sidewall isabout equal or less than a radial height of the crest portion of thehelical thread from the surface of the sidewall.
 8. The medicalconnector according to claim 6, wherein the at least one deformableprotrusion is a rib oriented about parallel to a central axis of thebody of the medical connector.
 9. The medical connector according toclaim 6, wherein the at least one deformable protrusion is detachablyconnected to at least one of the flank portions of the helical thread.10. The medical connector according to claim 1, further comprising: amating connector including a body having a distal end, a proximal end,and a generally cylindrical sidewall extending between the distal endand the proximal end, and a helical thread extending radially outwardfrom a surface of the sidewall, the helical thread of the matingconnector adapted to engage the helical thread of the medical connector.11. The medical connector according to claim 10, wherein the at leastone deformable stop is configured to engage the distal end of the matingconnector when the medical connector is connected with the matingconnector.
 12. The medical connector according to claim 1, wherein acircumferential width of the at least one deformable stop increases (i)as a radial distance of the at least one deformable stop from thesurface of the sidewall decreases, or (ii) as an axial distance of theat least one deformable stop from the proximal end of the bodydecreases.
 13. A medical connector comprising: a body having a distalend, a proximal end, and a sidewall extending between the distal end andthe proximal end; a helical thread extending radially outward from asurface of the sidewall and comprising a crest portion, flank portions,and a root portion, the flank portions connecting the crest portion tothe root portion; and at least one deformable stop extending radiallyoutward from the surface of the sidewall at the proximal end of thebody, wherein a circumferential width of the at least one deformablestop increases (i) as a radial distance of the at least one deformablestop from the surface of the sidewall decreases or (ii) as an axialdistance of the at least one deformable stop from the proximal end ofthe body decreases.
 14. The medical connector of claim 13, furthercomprising at least one deformable protrusion separate from the at leastone deformable stop, wherein a radial height of the at least onedeformable protrusion from the surface of the sidewall is about equal orless than a radial height of the crest portion of the helical threadfrom the surface of the sidewall.
 15. A method of connecting a medicalconnector to a mating connector, the method comprising: providing themedical connector, wherein the medical connector comprises: a bodyhaving a distal end, a proximal end, and a sidewall extending betweenthe distal end and the proximal end; a helical thread extending radiallyoutward from a surface of the body; a connecting surface connected to orintegral with the proximal end of the body; and at least one deformablestop extending radially outward from the surface of the sidewall at theproximal end of the body and extending proximally from the connectingsurface; providing the mating connector, wherein the mating connectorcomprises a helical thread extending radially outward from a surface ofthe mating connector; engaging the helical thread of the matingconnector with the helical thread of the medical connector; advancingthe mating connector onto the medical connector by rotating the matingconnector, such that the distal end of the mating connector advancestowards the connecting surface of the medical connector; and engagingthe distal end of the mating connector to the at least one deformablestop of the medical connector, thereby increasing friction between themating connector and the medical connector and/or stopping theadvancement of the mating connector onto the medical connector.
 16. Themethod according to claim 15, wherein the medical connector furthercomprises at least one deformable protrusion extending radially outwardfrom a root portion of the helical thread, the method furthercomprising, prior to engaging the distal end of the mating connector tothe at least one deformable stop, engaging the at least one deformableprotrusion with the mating connector such that friction between themedical connector and the mating connector is increased when the atleast one deformable protrusion of the medical connector is deformed bythe helical thread of the mating connector as the mating connector isadvanced onto the medical connector.
 17. The method according to claim15, wherein a circumferential width of the at least one deformable stopincreases as a radial distance of the at least one deformable stop fromthe surface of the sidewall decreases.
 18. The method according to claim15, wherein a circumferential width of the at least one deformable stopincreases as an axial distance of the at least one deformable stop fromthe proximal end of the body decreases.
 19. The method according toclaim 15, wherein the at least one deformable stop is disposed at aproximal-most end of the helical thread of the medical connector. 20.The method of claim 15, wherein the medical connector comprises aplurality of the at least one deformable stops extending from theconnector surface in a distal direction and radially outwardly from thesurface of the sidewall of the medical connector.